FDA Issues Complete Response Letter for Nivolumab in BRAF-Mutant Melanoma

Source: OncLive, December 2015

The FDA has issued a complete response letter to Bristol-Myers Squibb informing the company that additional data were needed for its supplemental biologics license application (sBLA) for the use of single-agent nivolumab (Opdivo) in previously untreated patients with BRAF V600 mutation-positive advanced melanoma. The application was based on the CheckMate-066 trial and additional data for a BRAF-positive group.

In August 2015, an application for frontline nivolumab in patients with BRAF-wild type melanoma was delayed by 3 months, following the submission of data for the BRAF-mutant population. Following this delay, on November 23, 2015, the FDA approved nivolumab for the frontline BRAF wild-type indication; however, a decision was not handed down for the BRAF-positive group.

“As part of the complete response letter, the FDA indicated the need for additional data in the BRAF-mutated patient population," according to a statement released by the company. “Bristol-Myers Squibb is working to evaluate the request outlined by the FDA and will continue to work closely with the agency to determine whether additional data, currently under review, adequately addresses these comments."